Imagine having your loved one experience a serious personal injury, or worse yet, die during surgery due to a malfunctioning medical device that the doctor had just implanted. Normally in cases like this, survivors are able to sue the medical device manufacturer for some type of damages due to the defective device and get it banned and to protect others so that they wouldn’t be affected. Well, as of last month, the U.S. Supreme Court has ruled, in an 8 to 1 decision, that patients injured by medical devices can’t sue the manufacturer.
Seems hard to believe, but true. What’s more unbelievable is that the legal theory behind this ruling is that the Food and Drug Administration, FDA, the agency that approves the safety of drugs, medical devices and other consumables is doing a good job. With thousands of current recalls on medical devices, not to mention questionable pharmaceuticals and the record number of food contamination outbreaks, do we really trust the FDA is doing the best job possible to protect us?
The FDA’s own advisory committee found that “the agency is so underfunded and understaffed that it’s putting U.S. consumers at risk in terms of food and drug safety”. The FDA has 1,311 fewer employees than it had 14 years and a deteriorating budget with obsolete technology. Moreover, currently 80% of all drugs sold in the United States are currently made overseas and the number of inspectors has gone from 531 in 2003 to just 380 in 2006. How does this lack of inspections make our food and drug supply safer?
Last year the U.S. experienced record numbers of food and drug recalls. Many of our products are now coming from China and they have a dismal record of contaminated food and drugs. Your prior rights in personal injury cases due to defective products and product liability have been severely compromised. The FDA admits that they only are capable of inspecting 2% of the imports coming into this country. This is truly unacceptable and even the advisory committees are helpless to provide change without a major overhaul of federal funding and major budgetary increase from the congress. In an election year and with a financial crisis looming, that probably won’t happen.
Last year, the Journal of the American Medical Association, JAMA, wrote an extensive article on the role of litigation and the release of drug information entitled, “The Role of Litigation in Defining Drug Risks”. The article, written from the doctor’s point of view, argues that often they themselves are unaware of some of the adverse side effects of some drugs. Doctors learn about new drugs from publications of clinical trials or case reports, promotional materials and FDA approval letters. Sometimes the information is limited in nature and only through the discovery process do the accurate, balanced data become known. In addition, sometimes the FDA approves drugs for a specific condition and then the drug is used for other reasons. The system is clearly flawed and needs to be fair for all involved.